Nick Allan

Why a CoVID-19 Point of Care Diagnostic will help insure our future

What is a coronavirus and why a CoVID-19 Point of Care Diagnostic is so important

CoVID-19 Point of Care Diagnostic

Transmission Electron micrograph of a Coronavirus.

The virus that causes CoViD19 is a coronavirus. The viruses are so called because the virus physically looks like a crown (‘corona’ derived from ancient Greek word for crown) when imaged by electron microscopy.  These coronaviruses are a group of enveloped single stranded RNA viruses which typically are responsible for the common cold. About seven kinds are known to cause an infection in humans.  Four of these are seasonal and cause the common cold year after year after year. The remaining three coronaviruses are termed emergent coronaviruses because they have been the cause of outbreaks and epidemics.

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Nigel Syrotuck

DIY COVID-19 Medical Devices

DIY COVID-19 medical devicesOne response to possible COVID-19 medical device shortages is to try to hack DIY COVID-19 medical devices together. It’s very empowering to see open-source communities come together to try to turn out a workable design to help avoid dire shortages for those in need. However, development of medical devices is far more nuanced than it might seem.

 

 

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Hannah Rusak-Gillrie

Adjusting Human Factors Processes for COVID-19: Remote Creativity

Human Factors Processes for COVID-19

©duiwoy55

New COVID-19 measures to protect our safety limit some human factors usability studies from being executed through traditional in-person facilitation. This blog identifies creative ‘COVID-19 friendly’ solutions to combat logistical hurdles for human factors research and evaluation activities supporting medical device product development.

 

 

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Alexandra Reid

FDA Guidance on Non-Clinical Bench Performance Testing Information

Your Roadmap for Premarket Submissions

Non-Clinical Bench Performance Testing Information
Are you wondering how best to organize your test plans and reports to make them submission ready? Look no further. The FDA provides a roadmap to follow for your premarket submission in their new guidance, ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’.

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Brian King

Using Monte Carlo Simulation for Biomedical Device Design

Monte Carlo Simulation
Light from biomedical devices interacts with human tissue, which contains a variety of structures and cell sizes and shapes. In many cases, optical scattering plays a strong role in the propagation of optical radiation. One common approach to simulating scattering is the Monte Carlo technique. Popular optics-simulation software incorporates Monte Carlo scattering, allowing you to circumvent the need to create your own code. However, a custom implementation allows for greater control of the simulation – and will certainly sharpen your understanding of how the technique works.

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Dana Trousil

Clean or Sterile medical device: How clean does it need to be?

Clean or Sterile Medical devices often come into contact with patients, and users. Sometimes repeatedly. Addressing patient and user contact is a critical aspect of medical device development. Biocompatibility is a significant aspect of contact, but what about sterility? And if a device does not need to be sterile, then how clean does it need to be?

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Nick Allan

5 biological sciences medical device breakthroughs for this decade

 biological sciences medical device breakthroughs Biological sciences medical device breakthroughs for this decade have a solid base to build upon. 3D tissue printing, advancements in cell therapy and regenerative medicine and gene editing breakthroughs were developed and adopted in the last decade.   Developing these technologies into commercial products and practical medical devices will be the work of the 2020 decade.

 

Here are my top 5 medical device breakthroughs that will be enabled by a partnership between biological sciences and engineering.

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